Standard versus Pre-emptive Antibiotic Treatment to Reduce the Rate of Infectious Outcomes after Whipple procedure (SPARROW): a multicenter, randomized controlled trial

The primary endpoint is the occurrence of a clinically relevant OSI and must

meet the following criteria (based on the CDC definition):

• A deep surgical site infection involving any part of the abdomen (e.g. organs

and/or spaces) other than the surgical incision within 90 days after surgery.

• AND Requires radiological, endoscopic or surgical intervention OR therapeutic

antibiotics required for an episode of sepsis, defined as two or more SIRS

criteria.

• AND Organisms isolated from an aseptically obtained culture.

The following secondary endpoints will be evaluated between patients receiving

perioperative prophylaxis versus pre-emptive antibiotic treatment (definitions

are outlined in Appendix A):

• OSI defined by the CDC definition within 90 days after surgery.

• Isolated OSI defined as an OSI without concurrent anastomotic leakage

(pancreatojejunostomy, hepaticojejunostomy or gastrojejunostomy). The concept

of an isolated OSI is used to separately classify abdominal infections without

concurrent anastomotic leakage.

• Superficial incisional SSI: defined according to the CDC definition: a

superficial surgical site infection occurring within 30 days after surgery

which involves superficial or deep soft tissue (skin, muscle or fascia, but no

intra-abdominal tissue), and at least one of the following criteria is present:

- Purulent drainage from the incision or subcutaneous tissue.

- Isolation of microorganisms from an aseptically obtained culture of fluid or

tissue from the superficial incision of subcutaneous tissue.

- Superficial infections of the skin or subcutaneous tissue which is

deliberately opened by a surgeon or attending physician OR at least one of the

following signs are present: localizes pain, tenderness, swelling, heat or

fever >38 degrees).

• Rate of clinically relevant postoperative pancreatic fistula (grade B or C

defined according to the ISGPS definition.

• Rate of bile and enteric leakage according to the ISGLS definition.

• Rate of postpancreatectomy hemorrhage according to the ISGPS definition.

• Rate of delayed gastric emptying according to the ISGPS definition.

• Rate of chyle leak according to the ISGPS definition.

• Rate of postoperative bacteraemia (defined as a positive blood culture)

• Rate of Clostridium difficile infection

• Rate of major complications, defined as a Clavien-Dindo score of >=III.

• Reintervention during admission (either radiological, surgical or endoscopic).

• ICU admission within 90 days after surgery.

• Length of hospital stay in days.

• Readmission within 90 days after surgery.

• In-hospital and 90-day mortality.

• Switch of postoperative antibiotics (including reason for deviation from

antibiotic protocol).

• Antibiotic sensitivity patterns in bile cultures and cultures from surgical

sites.

• Concordance of microorganisms in bile and surgical site cultures.